AN11--Research Services Reports Comparing Hip Prosthesis Device Development
Closed Special Notice Posted
- Solicitation number
- 36C24E25Q0049
- Agency
- Veterans Integrated Service Network 4 Veterans Health Administration, Department of Veterans Affairs
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541720 Research and Development in the Social Sciences and Humanities
- Points of contact
-
- Ann Marie Stewart annmarie.stewart@va.gov (401) 919-0878
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 4 has issued a Special Notice regarding their intent to award a sole source contract for hip prosthesis device development research services. The notice indicates the VA intends to negotiate a three-month firm fixed-price purchase order with Medical Device Development, a small business located at 2390 Mission St., Suite 8, San Francisco, CA 94110. This is a pre-solicitation notice and not an actual solicitation, as the contract will be awarded on a sole source basis under FAR 6.302.1-1 authority for "Only One Responsible Source." The contract falls under NAICS code 541720 with a $28 million standard and Product Service Code AN11 for Health R&D Services. The notice was posted on July 10, 2025, with a response deadline of July 16, 2025.
The primary purpose of this contract is to support the San Francisco VA Healthcare System's research department by conducting laboratory testing and evaluation comparing subject and predicate prostheses using both synthetic bones (sawbones) and human cadaveric bones. The FDA requires these comparative evaluations before allowing clinical use of the subject prostheses, making this work essential for regulatory approval. The VA justifies the sole source approach by citing that Medical Device Development was previously awarded a competitive contract for similar work involving human cadaveric bones, and maintaining continuity with the same contractor will prevent project delays and ensure consistent research outcomes. Since this is a sole source procurement, no competitive solicitation will be posted on SAM.gov, though interested parties may contact Contracting Officer Ann Marie Stewart at annmarie.stewart@va.gov regarding the procurement. The contracting officer retains sole discretion to determine whether to conduct a competitive procurement based on any responses received to this notice.
Notice text
Pre-Solicitation Notice for notice of intent to award a sole source contract. This is not a solicitation. The Department of Veterans Affairs intends to negotiate a sole source firm fixed price purchase order for a three-month period with Medical Device Development, 2390 Mission St., Suite 8, San Francisco, CA 94110, to support the US Department of Veterans Affairs (VA) research office. This requirement is for Medical Device Development, a small business, to provide an evaluation and reports comparing the subject and predicate prostheses in laboratory tests, using synthetic bones ( sawbones ) and human cadaveric bones for the San Francisco VA Healthcare System, research department.
The FDA requires the evaluation of the predicate and subject prostheses in both a synthetic bone model and in human cadaveric bones before allowing clinical use of the subject prostheses. Medical Device Development was awarded the previous contract for evaluation of the predicate and subject prostheses in human cadaveric bones using competitive procedures. This requirement is a continuation of the previous contract and part of a larger research project. To maintain continuity in this project, the recommendation is to sole source this three-month requirement to Medical Device Development. Contracting out to a different source will delay the project and lead to discordant outcomes between the results for synthetic bones and human cadaveric bones.
Since the intent is to procure this on a sole source basis, no solicitation will be posted on SAM.gov (Contract Opportunities). The applicable NAICS code is 541720 with a $28MIL standard. The PSC is AN11. The authority for this action is FAR 6.302.1-1 Only One Responsible source and no other supplies or services will satisfy agency requirements.
Interested persons may contact the Contracting Officer via email at annmarie.stewart@va.gov regarding this procurement. The determination to conduct a competitive procurement based on responses to this notice is solely within the discretion of the Contracting Officer.
Attachments
| File | Type | Posted |
|---|---|---|
| 36C24E25Q0049.docx | DOCX document |
On GovTribe
Work this opportunity on GovTribe
- Track it in your pipeline
- Find teaming partners
- Similar opportunities
- Ask GovTribe AI about this opportunity